DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
FDA device recall Z-2354-2026 · posted 2026-06-05 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
- Action taken
- Philips Medical notified the single consignee on about 05/01/2026 via mailed letter. The consignee was notified of the issue, potential risk, and instructed to Stop using the Wall Stand VS2 immediately to ensure patient and user safety while Philips provides the Seismic Bucky Unit 2 (BU2) Skyplate kit, do not attempt to inspect, adjust, or install any mechanical components of the Wall Stand yourself, circulate this Urgent Medical Device Correction letter to all users of this device so that they are aware of the issue and associated impact, and complete and return the provided response form. A Philips representative will contact the consignee to schedule a time for a Field Service Engineer (FSE) to visit the site to install a hardware correction.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MQB
- Quantity affected
- 1 unit
- Distribution
- US distribution to California.
- Date initiated
- 2026-05-01
- Date posted
- 2026-06-05
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DigitalDiagnost C90 (K202564) | Philips Medical Systems Dmc GmbH | 2020-09-30 |